MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK4XDPTSW
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Difficult or Delayed Activation (2577); Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on a laparoscopic ventral hernia repair, while fixating the mesh, the ¿push to reload¿ button was difficult to press.The green and red buttons would also not toggle back and forth.Another tacker was used but there were issues with the reloads.The surgeon tried switching the standard and deep purchase tacks; however the reloads could not be interchanged.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted no abnormalities.One 8 dpt single use loading unit (sulu) with a full complement of tacks, proper timing and the shipping wedge attached was received.No scratches were noted on the inner tube of the sulu.The articulation knob functioned properly.Additionally, the handle could be actuated and cycled properly with no sulu attached.The returned reload could be loaded onto the returned instrument.The instrument was applied to the appropriate test media.All eight tacks deployed and seated properly in the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9504092
• Report Number: 1219930-2019-07095
• Device Sequence Number: 19333368
• Product Code: GDW
• UDI-Device Identifier: 10884521726383
• UDI-Public: 10884521726383
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: RELTACK4XDPTSW
• Device Catalogue Number: RELTACK4XDPTSW
• Device Lot Number: N8G0299UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1